Feasibility of home monitoring of visual function in DR
Research type
Research Study
Full title
Investigating the feasibility of home monitoring of visual function in populations at high risk of developing Diabetic Retinopathy (DR) using novel game-based technology (OKKO Health)
IRAS ID
307008
Contact name
Ruth Hogg
Contact email
Sponsor organisation
Queen's University Belfast
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 11 months, 1 days
Research summary
Summary of Research
Diabetes is a serious condition where patients can develop complications in their body including their eyes which can lead to sight loss. Patients with diabetes are encouraged to attend yearly screening appointments at which signs of Diabetic Retinopathy (DR) are assessed. Attendance at these appointments and at any follow-up appointments can be time-consuming and inconvenient for those working. Better ways to monitor changes in vision are needed. Therefore, we are hoping to develop a set of eye tests that a person with diabetes can complete at home on a smartphone in collaboration with researchers at OKKO Health.
Study Aims:
(1) Evaluate performance and acceptability of longitudinal monitoring in patients at high risk of developing DR (i) During pregnancy in patients with pre-gestational diabetes (ii) Patients with DR in one eye (fellow eye high risk) and those hard to reach clinically e.g., Dialysis patients with Diabetes.
(2) Explore the relationship between changes in visual function over time as assessed using the OKKO app at home with fluctuations in blood glucose in persons with diabetes who use a continuous blood glucose device in the United Kingdom.Study 1: The study will involve 2 scheduled clinic visits within the Belfast HSC trust and use of the app for up to 6 months inbetween. We estimate recruiting 15-20 patients in each group (pregnancy group 20 x 2 visits, unilateral DR 15 x 2 visits, and dialysis patients 20 x 2 visits) 55 patients. We estimate 110 patient encounters in total.
Study 2: This study will take place over the course of 12 months (with 3 months for recruitment, 6 months for patient home monitoring, and 3 months of analysis). The 35 participants with diabetes (Diabetic Retinopathy stage R0 or R1) will be asked to use the app at least once a week for the duration of the follow-up time study (6 months).
Summary of Results
We recruited 55 people across three high-risk groups: 14 dialysis patients, 14 pregnant women with diabetes, and 27 people using continuous glucose monitoring (CGM). Participants were asked to test their vision at home (or during dialysis visits) using the OKKO Health smartphone app over a 6-month period.Recruitment and retention patterns differed between the groups. The CGM group showed the most initial interest, but many people dropped out before officially joining due to remote recruitment, only half signed up. However, once enrolled, most participants stayed until the end. The dialysis and pregnancy groups faced fewer initial barriers as recruitment happened in-clinic, and while they started with smaller numbers, they retained participants well. Dropouts occurred for different reasons. In the CGM group, non-participation was mostly due to lack of communication, unsuitable devices or difficulty using the technology from home. In contrast, dropouts in the pregnancy and dialysis groups were more often linked to health issues, such as illness or pregnancy complications.
Patterns of app use also varied. Dialysis patients used the app steadily, and older patients tended to play more often than younger ones, supported by the structure of testing during routine clinic visits. The pregnancy group showed a decline in app use over time, followed by some recovery at the end of the six months. Younger women were more likely to resume using the app, while older participants engaged less towards the end, leading to more inconsistent use. CGM users showed stable use overall, but levels of engagement varied widely between individuals. Older participants in this group tended to play more frequently.
The acceptability of the app also differed between groups. Dialysis patients became less likely to see the app as useful or easy to use as the study went on. Some found the screen harder to read and highlighted problems with accessing a suitable device. The pregnancy group reported no major changes in how acceptable or useful they found the app across the study period. By contrast, CGM users became less confident and motivated over time, and were less likely to believe that using the app weekly would help prevent sight loss.
Support needs also varied. Very few dialysis participants owned smartphones, meaning most support had to be provided in-clinic. Pregnancy and CGM participants used their own devices at home, but they required a lot of researcher support to stay engaged. The pregnancy group needed 110 support interactions, including phone calls, clinic visits and emails, while the CGM group needed far more, with 624 interactions and over 7,000 minutes of researcher time.
Participants also shared feedback about their experience. Some found the vision tests easy, while others found them difficult, and it was not always clear whether this was due to the design of the games or changes in their vision caused by diabetes. Many felt that lighting conditions at home, particularly in dim or artificial light, made testing harder compared to well-lit clinic environments. On the positive side, most participants found the app simple to use, with clear instructions and enjoyable features such as relaxing background music. A stylus was provided to dialysis patients and was described as helpful.
When asked about the games themselves, people generally preferred the simpler ones, while more difficult games were less popular. There were mixed views on how often tests should be done. Some liked weekly testing, while others felt that six months of regular use was too long or too demanding. Overall, the app was often described as fun and engaging, with the different types of games helping to maintain interest. However, several participants suggested that more variety, colours and new games would improve their experience. Some also described a learning curve, saying it took a few attempts to get used to the games. A recurring theme was that participants would only want to use the app if their vision was getting worse, rather than as part of routine monitoring.
In summary, this study showed that home vision monitoring using a smartphone app is possible for people in high-risk groups, but there are challenges. Older people tended to engage more often, but access to devices was a problem for some. Pregnant women and dialysis patients faced unique health-related barriers that interrupted their use, while long-term engagement was difficult to maintain when people did not see an immediate personal benefit. While the app was generally well liked, sustained use may depend on making it more engaging, providing stronger support, and showing more clearly how it can help protect sight.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0019
Date of REC Opinion
27 Feb 2023
REC opinion
Favourable Opinion